NCT04023162

Brief Summary

This study investigates the effect of two physiotherapy models in the treatment of chronic nonspecific low back pain. Participants will be divided into three groups, two experimental and one control. In both experimental groups, the participants will be included in the intensive program of Therapy Exercises, under the supervision and guidance of the physiotherapist, and the group will differ in implemented behavioral therapy (which he will implement by a physiotherapist). In the control group, subjects will receive the usual treatment. The Back School will be applied in all groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

March 7, 2022

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

July 14, 2019

Last Update Submit

February 18, 2022

Conditions

Chronic Nonspecific Low Back Pain

Keywords

Low Back PainNonspecificOperant ConditioningGraded ActivityTherapy Exercise

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analog Scale (VAS) Pain Score

    Self-reported pain intensity, Each item scored 0-100 mm (0=No pain; 100=Pain as bad as can be).

    Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

Secondary Outcomes (8)

  • Change in Roland Morris Disability Questionnaire (RMDQ) Score

    Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  • Change in Goniometry of spine (ROM) Score

    Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  • Change in Finger to Floor Test (FTF)

    Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  • Change in Prone Double Straight Leg Raise Test (PDSLRT) Score

    Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  • Change in Hospital Anxiety and Depression Scale (HAD) Score

    Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  • +3 more secondary outcomes

Study Arms (3)

Biomedical (Physiotherapy) group

EXPERIMENTAL

Therapy Exercise and Back School; 8 sessions during 4 weeks (2 times a week), with one session lasting 60 min.

Behavioral: Group-based Therapy ExerciseBehavioral: Back School

Biopsychosocial (Graded Activity) group

EXPERIMENTAL

Operant Conditioning implement in Physiotherapy, Therapy Exercises and Back School; 8 sessions during 4 weeks (2 times a week), with one session lasting 60 min.

Behavioral: Graded ActivityBehavioral: Group-based Therapy ExerciseBehavioral: Back School

Usual care

NO INTERVENTION

Usual care and written instructions on Therapy Exercise and Back School for self-care.

Interventions

Graded ActivityBEHAVIORAL

Active participation of participants, Overcoming and eliminating negative behaviors, Encouraging positive behavior in pain, Overcoming the fear of the movement, Motivation to implementation pre-set specific goals.

Also known as: Physiotherapy - Provided Operant Conditioning
Biopsychosocial (Graded Activity) group
Group-based Therapy ExerciseBEHAVIORAL

Aerobic exercise, Stretching exercise and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercise Muscle strength training exercise

Also known as: Exercises Therapy, Kinesitherapy
Biomedical (Physiotherapy) groupBiopsychosocial (Graded Activity) group
Back SchoolBEHAVIORAL

Basic information of Low Back Pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.

Biomedical (Physiotherapy) groupBiopsychosocial (Graded Activity) group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People with a diagnosis of nonspecific pain in the spinal area with symptoms of pain 3 and \> months, confirmed by a doctor specialist family medicine,
  • Age from 18 to 75 years of life,
  • Both sexes.

You may not qualify if:

  • Acute and Subacute low back pain,
  • Specific Low Back Pain,
  • Operative interventions on the spine,
  • Other health problems of the patient: pregnancy or gynecological diseases, blood vessels, elevated blood pressure, malignant and benign tumors in the spine, spinal abnormalities, spinal traumas, urological disorders and psychological disorders,
  • Mental health problems that prevent the verbal expression and understanding of the questionnaire, and
  • People who have been included in the therapeutic exercise program for the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dom zdravlja Mostar

Mostar, 88000, Bosnia and Herzegovina

Location

Rehabilitacijski centar "Život"

Mostar, 88000, Bosnia and Herzegovina

Location

Related Publications (10)

  • Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil. 2014 May;95(5):986-995.e1. doi: 10.1016/j.apmr.2013.10.032. Epub 2014 Jan 21.

    PMID: 24462839BACKGROUND

  • Wong JJ, Cote P, Sutton DA, Randhawa K, Yu H, Varatharajan S, Goldgrub R, Nordin M, Gross DP, Shearer HM, Carroll LJ, Stern PJ, Ameis A, Southerst D, Mior S, Stupar M, Varatharajan T, Taylor-Vaisey A. Clinical practice guidelines for the noninvasive management of low back pain: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Eur J Pain. 2017 Feb;21(2):201-216. doi: 10.1002/ejp.931. Epub 2016 Oct 6.

    PMID: 27712027BACKGROUND

  • Henschke N, Ostelo RW, van Tulder MW, Vlaeyen JW, Morley S, Assendelft WJ, Main CJ. Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD002014. doi: 10.1002/14651858.CD002014.pub3.

    PMID: 20614428BACKGROUND

  • Hall A, Richmond H, Copsey B, Hansen Z, Williamson E, Jones G, Fordham B, Cooper Z, Lamb S. Physiotherapist-delivered cognitive-behavioural interventions are effective for low back pain, but can they be replicated in clinical practice? A systematic review. Disabil Rehabil. 2018 Jan;40(1):1-9. doi: 10.1080/09638288.2016.1236155. Epub 2016 Nov 21.

    PMID: 27871193BACKGROUND

  • Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR; Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010 Mar 13;375(9718):916-23. doi: 10.1016/S0140-6736(09)62164-4. Epub 2010 Feb 25.

    PMID: 20189241BACKGROUND

  • Gordon R, Bloxham S. A Systematic Review of the Effects of Exercise and Physical Activity on Non-Specific Chronic Low Back Pain. Healthcare (Basel). 2016 Apr 25;4(2):22. doi: 10.3390/healthcare4020022.

    PMID: 27417610BACKGROUND

  • National Collaborating Centre for Primary Care (UK). Low Back Pain: Early Management of Persistent Non-specific Low Back Pain [Internet]. London: Royal College of General Practitioners (UK); 2009 May. Available from http://www.ncbi.nlm.nih.gov/books/NBK11702/

    PMID: 20704057BACKGROUND

  • Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015 Dec;29(12):1155-67. doi: 10.1177/0269215515570379. Epub 2015 Feb 13.

    PMID: 25681408BACKGROUND

  • Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.

    PMID: 21982256RESULT

  • Hrkac A, Bilic D, Cerny-Obrdalj E, Baketaric I, Puljak L. Comparison of supervised exercise therapy with or without biopsychosocial approach for chronic nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Nov 8;23(1):966. doi: 10.1186/s12891-022-05908-3.

    PMID: 36348309DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Antonija Hrkać

    Faculty of Health Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of interventions that will be applied in this study, blinding of therapists who will carry out the intervention regarding Therapy Exercise will not be possible to implement, but physiotherapists (apart from the study designer) will not know the study hypothesis. Fully blinding of the examinees is also impossible to implement, but partially blinding will occur, as the participants in the Graded Activity group will not explain the applied behavioral therapy. Blinding will be applied to researchers who will collect data (measure outcomes) and statisticians.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: By randomization, the participants will be divided into three groups, two experimental groups, and a control group. In the first experimental group, the investigated interventions will consist of Therapy Exercise and Back School. In the second experimental group, in addition to the Therapy Exercise and the Back School, operative conditioning will be performed by the master of physiotherapy. The participants in the control group will be exposed to the usual treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master of Physiotherapy, Postgraduate Study in Health Sciences

Study Record Dates

First Submitted

July 14, 2019

First Posted

July 17, 2019

Study Start

July 22, 2019

Primary Completion

February 28, 2020

Study Completion

April 30, 2020

Last Updated

March 7, 2022

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

All of individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 3 months and ending 5 years following article publication.
Access Criteria
Anyone who wishes to access the data.

Locations

BO(2)